A substantial portion of medications are not taken as prescribed. By some estimates, in clinical practice up to 50% or more of medications either may not be taken at all or may be taken with significant deviations from what is prescribed for the patient. For example, doses of a medication may be skipped, the medication may not be taken at the right intervals, at the right times, in the right dose, applied in the correct manner, etc. Such deviation from a prescribed medication regimen may be referred to broadly as “nonadherence”. Nonadherence to prescribed medication regimens may have dramatic negative effects on health and/or healthcare costs, whether considering individuals or societies collectively.
Nonadherence may be even more common in clinical research, wherein some estimates indicate nonadherence of up to 70% or more. Nonadherence in a research context also presents other potential concerns. For example, testing of new medications typically may include efforts to determine the effectiveness of the medication, what side effects occur, how severe those side effects may be, in what fraction of the population those side effects occur, etc. Thus nonadherence in a research setting may distort the basic understanding of a medication, e.g., if a medication is in fact highly effective if taken as prescribed but ineffective or dangerous if not taken properly, poor adherence within a clinical trial may result in data showing that the medication is not effective (when the actual problem is that it was not taken correctly).
One matter complicating issues related to nonadherence is that reliable data on the existence, degree, and form(s) of nonadherence present may be difficult to acquire. Whether for an individual, a larger population, or even a carefully selected and/or monitored group such as the subjects in a clinical trial, authentic data on how much nonadherence is taking place, among whom, and in what forms (e.g., missing doses, taking the medication incorrectly, etc.) may not be available through conventional sources. Without such authenticated data it may not even be known how much nonadherence is taking place (beyond estimates), much less what the specific impacts of nonadherence may be in a given case.
At least in principle, it may be possible to detect, record, and/or report the use of a medication through making medication containers “smart”. However, such an approach also presents challenges. For example, medication containers that are handled and/or carried regularly may be subject to various environmental hazards, e.g., the container may get wet, be dropped, be sat upon (for example if kept in a pocket), be exposed to extreme temperatures (for example if left in a car on a hot day or kept in an outer coat pocket in very cold weather), be bumped or compressed by other objects in a pocket or bag, etc. In addition to potential issues of fragility, sensors, processors, a data stores, communicators, power sources, etc., as may be adequate to provide smart functionality may add significant cost, weight, bulk, etc. to a container.
In addition, even if a medication container is smart in itself, it may be useful to communicate data acquired thereby to some other entity. This typically may require either a physical connection, or a wireless connection. Neither is without concerns. A requirement to regularly make a physical connection to download data may simply “kick the can down the road”, in that if a patient cannot be relied upon to take a medication regularly then that patient also may not download data regularly, either. On the other hand wireless communication may require additional power, additional components for wireless communication, etc., and may present challenges regarding reliability, interference with/from other electronic devices, etc.
It is also noted that medication containers may be designed only to be used for limited periods, e.g., for 30 days until empty, for a single application of medication, after which the containers—and smart components thereon—may be discarded. Thus it may be particularly useful if components in or on the container (whether for smart functionality or otherwise) are simple, robust, inexpensive, easily recycled, etc.